Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00003745




Registration number
NCT00003745
Ethics application status
Date submitted
1/11/1999
Date registered
27/01/2003
Date last updated
5/02/2013

Titles & IDs
Public title
Chemotherapy in Treating Children With Recurrent or Refractory Sarcomas
Scientific title
A Phase II Study of Continuous 21 Day Infusion of Topotecan (NSC # 609699) in Children With Relapsed Solid Tumors
Secondary ID [1] 0 0
COG-A09713
Secondary ID [2] 0 0
NCI-2012-01841
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sarcoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue
Cancer 0 0 0 0
Bone

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Arm I - Patients receive topotecan IV continuously on days 1-21. Treatment continues at least every 4 weeks in the absence of unacceptable toxicity or disease progression.
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

* Histologically confirmed malignancy that is relapsed or refractory to conventional therapy at original diagnosis including:

* Brain tumors

* Gliomas or astrocytomas
* Medulloblastomas or primitive neuroectodermal tumor (PNET) in CNS
* (Brain tumor stratum closed to accrual effective 07/02/2001)
* Sarcomas

* Soft tissue sarcoma (undifferentiated sarcoma, embryonal or alveolar rhabdomyosarcoma (RMS), or non-RMS soft tissue sarcoma)
* Osteosarcoma
* Ewing's sarcoma/peripheral PNET tumors
* Neuroblastoma

* (Neuroblastoma stratum closed to accrual effective 07/02/2001)
* Histology requirement waived for brain stem tumors (Brain tumor stratum closed to accrual effective 07/02/2001)
* Measurable disease documented by clinical, radiographic, or histologic criteria
* Lesions in previously irradiated fields may be used to assess tumor response if there has been evidence of subsequent tumor growth in those fields
* No bone marrow metastases with granulocytopenia and/or thrombocytopenia

PATIENT CHARACTERISTICS:

Age:

* 30 days to 21 years at diagnosis

Performance status:

* ECOG 0-2

Life expectancy:

* More than 2 months

Hematopoietic:

* Absolute neutrophil count at least 1,000/mm3
* Hemoglobin at least 10.0 g/dL (may receive RBC transfusions)
* Platelet count at least 100,000/mm3 (50,000/mm3 if post bone marrow transplantation) (transfusion independent)

Hepatic:

* Bilirubin no greater than 1.5 times normal
* SGOT or SGPT less than 2.5 times normal

Renal:

* Creatinine no greater than 1.5 times normal OR
* Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min

Neurologic:

* No greater than grade 2 CNS toxicity OR
* Stable CNS status for brain tumors (Brain tumor stratum closed to accrual effective 07/02/2001)
* Seizure disorders allowed if well-controlled with anticonvulsants

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 3 months since prior bone marrow transplantation and recovered
* At least 2 weeks since prior cytokines and recovered
* No concurrent filgrastim (G-CSF) or other cytokines
* No concurrent immunomodulating agents

Chemotherapy:

* At least 2 weeks since prior chemotherapy (4 weeks for nitrosoureas) and recovered
* No prior topotecan or other camptothecins
* No other concurrent anticancer chemotherapy

Endocrine therapy:

* Concurrent corticosteroids for CNS tumors with increased intracranial pressure allowed (Brain tumor stratum closed to accrual effective 07/02/2001)

Radiotherapy:

* At least 2 months since prior craniospinal radiotherapy or radiotherapy to more than 50% of the bone marrow and recovered
* Concurrent radiotherapy to localized painful lesions allowed provided that at least 1 measurable lesion is not irradiated

Other:

* Recovered from any other prior therapy
Minimum age
No limit
Maximum age
21 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/1999
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
125
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Sydney Children's Hospital - Randwick
Recruitment hospital [2] 0 0
Children's Hospital at Westmead - Westmead
Recruitment hospital [3] 0 0
Royal Children's Hospital - Brisbane
Recruitment hospital [4] 0 0
Women's and Children's Hospital - North Adelaide
Recruitment hospital [5] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [6] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4029 - Brisbane
Recruitment postcode(s) [4] 0 0
5006 - North Adelaide
Recruitment postcode(s) [5] 0 0
3052 - Parkville
Recruitment postcode(s) [6] 0 0
6001 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Delaware
Country [8] 0 0
United States of America
State/province [8] 0 0
District of Columbia
Country [9] 0 0
United States of America
State/province [9] 0 0
Florida
Country [10] 0 0
United States of America
State/province [10] 0 0
Georgia
Country [11] 0 0
United States of America
State/province [11] 0 0
Hawaii
Country [12] 0 0
United States of America
State/province [12] 0 0
Idaho
Country [13] 0 0
United States of America
State/province [13] 0 0
Illinois
Country [14] 0 0
United States of America
State/province [14] 0 0
Indiana
Country [15] 0 0
United States of America
State/province [15] 0 0
Iowa
Country [16] 0 0
United States of America
State/province [16] 0 0
Kansas
Country [17] 0 0
United States of America
State/province [17] 0 0
Kentucky
Country [18] 0 0
United States of America
State/province [18] 0 0
Louisiana
Country [19] 0 0
United States of America
State/province [19] 0 0
Maine
Country [20] 0 0
United States of America
State/province [20] 0 0
Maryland
Country [21] 0 0
United States of America
State/province [21] 0 0
Massachusetts
Country [22] 0 0
United States of America
State/province [22] 0 0
Michigan
Country [23] 0 0
United States of America
State/province [23] 0 0
Minnesota
Country [24] 0 0
United States of America
State/province [24] 0 0
Mississippi
Country [25] 0 0
United States of America
State/province [25] 0 0
Missouri
Country [26] 0 0
United States of America
State/province [26] 0 0
Nebraska
Country [27] 0 0
United States of America
State/province [27] 0 0
Nevada
Country [28] 0 0
United States of America
State/province [28] 0 0
New Hampshire
Country [29] 0 0
United States of America
State/province [29] 0 0
New Jersey
Country [30] 0 0
United States of America
State/province [30] 0 0
New Mexico
Country [31] 0 0
United States of America
State/province [31] 0 0
New York
Country [32] 0 0
United States of America
State/province [32] 0 0
North Carolina
Country [33] 0 0
United States of America
State/province [33] 0 0
North Dakota
Country [34] 0 0
United States of America
State/province [34] 0 0
Ohio
Country [35] 0 0
United States of America
State/province [35] 0 0
Oklahoma
Country [36] 0 0
United States of America
State/province [36] 0 0
Oregon
Country [37] 0 0
United States of America
State/province [37] 0 0
Pennsylvania
Country [38] 0 0
United States of America
State/province [38] 0 0
Rhode Island
Country [39] 0 0
United States of America
State/province [39] 0 0
South Carolina
Country [40] 0 0
United States of America
State/province [40] 0 0
South Dakota
Country [41] 0 0
United States of America
State/province [41] 0 0
Tennessee
Country [42] 0 0
United States of America
State/province [42] 0 0
Texas
Country [43] 0 0
United States of America
State/province [43] 0 0
Utah
Country [44] 0 0
United States of America
State/province [44] 0 0
Vermont
Country [45] 0 0
United States of America
State/province [45] 0 0
Virginia
Country [46] 0 0
United States of America
State/province [46] 0 0
Washington
Country [47] 0 0
United States of America
State/province [47] 0 0
West Virginia
Country [48] 0 0
United States of America
State/province [48] 0 0
Wisconsin
Country [49] 0 0
Canada
State/province [49] 0 0
Alberta
Country [50] 0 0
Canada
State/province [50] 0 0
British Columbia
Country [51] 0 0
Canada
State/province [51] 0 0
Manitoba
Country [52] 0 0
Canada
State/province [52] 0 0
Newfoundland and Labrador
Country [53] 0 0
Canada
State/province [53] 0 0
Nova Scotia
Country [54] 0 0
Canada
State/province [54] 0 0
Ontario
Country [55] 0 0
Canada
State/province [55] 0 0
Quebec
Country [56] 0 0
Canada
State/province [56] 0 0
Saskatchewan
Country [57] 0 0
Netherlands
State/province [57] 0 0
Groningen
Country [58] 0 0
New Zealand
State/province [58] 0 0
Auckland
Country [59] 0 0
Puerto Rico
State/province [59] 0 0
San Juan
Country [60] 0 0
Puerto Rico
State/province [60] 0 0
Santurce
Country [61] 0 0
Switzerland
State/province [61] 0 0
Bern
Country [62] 0 0
Switzerland
State/province [62] 0 0
Geneva
Country [63] 0 0
Switzerland
State/province [63] 0 0
Lausanne

Funding & Sponsors
Primary sponsor type
Government body
Name
National Cancer Institute (NCI)
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Douglas Hawkins, MD
Address 0 0
Seattle Children's Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents


Results not provided in https://clinicaltrials.gov/study/NCT00003745